SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT


Device Classification Name

catheter, conduction, anesthetic

510(k) Number K081404
Device Name SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT
Applicant
SPINAL INTEGRATION LLC
6314 kingspointe pkwy unit 6
orlando, 
FL 
32819

Applicant Contact trudie l seeger
Correspondent
SPINAL INTEGRATION LLC
6314 kingspointe pkwy unit 6
orlando, 
FL 
32819

Correspodent Contact trudie l seeger
Regulation Number 868.5120
Classification Product Code
BSO  
Date Received 05/19/2008
Decision Date 10/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No